The present invention relates, in general, to skin treatments using hose or other garments made of hose material that is worn tightly on the skin, and, in particular, to a new and useful product, method of making the product and treatment method using the product, which first chemically binds an active ingredient to the hose material by semi-duralite bond, and then releases the active ingredient to the skin while the hose material is worn by breaking the semi-durable bond using skin conditioners such as pH, moisture and/or heat. In the preferred embodiment of the invention the hose material is nylon, the active ingredient is theophylline and the treatment is for cellulite.
Cellulite is an accumulation of fatty tissue in the upper layers of the skin which is manifested as a xe2x80x9cmattress buttonxe2x80x9d defect in the skin. It is known that a class of physiological ingredients known as xanthines are capable of reducing fatty tissue in underlying skin if applied topically. The most common xanthines are caffeine, theophylline and theobromine. Theophylline is the most common xanthine used in the treatment of cellulite.
U.S. Pat. No. 4,288,433 to Koulbanis et al. teaches using xanthine compounds, of which theophylline is one (caffeine is another), to treat cellulite. The xanthine compounds are combined with other chemical groups, or radicals, such as alkyls, allyls, propynols and cyclohexyls.
A composition containing xanthine compounds mixed with alpha hydroxy acid and/or phytic acid for applying to cellulite-affected areas is the subject of U.S. Pat. Nos. 5,523,090 and 5,536,499, both to Znaiden et al. The compound is disclosed for direct application to a user""s skin.
U.S. Pat. No. 5,051,449 to Kligman et al. uses retinoid compounds applied directly to the skin to treat cellulite. The retinoid compound is preferably retinoic acid mixed in a commercial lotion.
A heated massager for use in treating cellulite is disclosed in U.S. Pat. No. 4,086,922 to Henderson.
Other patents disclose the use of theophylline compounds to treat various medical disorders, such as U.S. Pat. No. 3,962,243 to Roldan et al., which teaches the use of mepyramine theophylline acetate to treat bronchial disorders and relieve the effects of histamine poisoning. Mepyramine is combined with a suspension of 7-theophylline acetic acid to form the claimed compound of Roldan ""243.
A stable form of a theophylline compound is disclosed in U.S. Pat. No. 4,085,214 to Higuchi et al. Higuchi ""214 combines theophylline with a phenylalkenyl group having 2-8 carbons in the alkenyl portion to provide a theophylline drug useful in treating asthma.
U.S. Pat. No. 4,241,682 to Konstandt discloses coating boats with polyethylenimine solutions to improve the movement of the boats through water.
Patents on pantyhose or articles of clothing having cosmetic treatment properties include U.S. Pat. No. 4,152,784 to McGalliard for a nylon hose treated with a microencapsulated depilatory. The depilatory is released to a wearer""s skin while the hose are worn when microcapsules are ruptured by contact with hair stubble. EP 009,499 to McGalliard corresponds to U.S. Pat. No. 4,152,784.
A method of treating cellulite by wrapping the affected portions of a persons"" body with a body wrap soaked in a mineral solution and then exercising while wearing a vinyl exercise suit is taught by U.S. Pat. No. 4,829,987 to Stewart. The mineral solutions of Stewart ""987 must be warmed and leave a residue on the person""s body when done. The mineral solutions are more fully discussed in a book cited in the patent. The mineral solutions appear to be very different from the THA compounds of the invention.
A sock having reduced friction with a wearer""s foot due to coating or impregnating, among other things, with a fluoropolymer is covered by U.S. Pat. No. 5,575,012 to Fox et al.
U.S. Pat. No. 5,051,256 to Barnes teaches an iodine compound which may be linked to Nylon-4 to provide an anti-bacterial fabric having an extended time-release of iodine as the active agent.
U.S. Pat. No. 5,156,843 to Leong et al. is for a fabric impregnated with coated microspheres to provide a controlled, time-release of the material used to coat the microspheres.
A transdermal delivery patch for a drug having the active substance microencapsulated and combined with a polymer skin enhancer is disclosed by U.S. Pat. No. 5,614,212 to D""Angelo et al. The skin enhancer is preferably polyvinylpyrrolidone, or PVP.
British Patent Specification GB 1,581,586 to Yamauchi discloses a stocking or panty hose having a solid sanitary composition which includes a water-insoluble resin binder having a metal dispersed within the binder.
GB 1,361,289 to Alza Corp. and European Application EP 436,729 Kanebo Ltd. both teach treatment compositions using microcapsules initially attached to a bandage or stocking to deliver the active ingredients to a person""s skin.
EP 174,108 to Jost discloses a porous, two-layer polymeric foam patch for transdermally delivering medicine to a person.
Italian Patent 1,191,244 to Alza Corp. corresponds to UK Patent 1,361,289 and to U.S. Pat. No. 4,435,180. These patents teach a treatment composition using microcapsules initially attached to a stocking to deliver the active ingredients to a person""s skin. The stocking provides a compressive force against the person""s skin to make good contact between the composition and the skin.
Italian Patent 951,409 to Eurand SpA discloses a method of applying microcapsules to textiles, such as for underwear or linens. The microcapsules contain a fragrance.
An injectable composition containing theophylline is taught by Italian Patent 1,093,259 in the name of Holzmann.
Italian Patents 1,191,962 to Malesci, 1,217,516 to Caroprese, 1,258,343 to Comi and 1,263,754 each disclose compositions for treating cellulite. The compositions of these patents are different from the inventive composition.
It has been found that compliance and time of application of cellulite reduction agents are critical to an effectiveness of the treatment. The present invention provides a product, method of making the product and treatment using the product which advances compliance and the extended time of treatment in an automatic manner by incorporating the active treatment ingredient into an article of closely fitting clothing, that is a garment, and in particular, hose.
A preferred embodiment of the present invention comprises a nylon pantyhose or stocking having polyethylenimine (PEI) permanently chemically bound by durable chemical bonds, to the nylon, and ionically bonded by a semi-durable chemical bond to theophylline acetate (THA), the active ingredient. The PEI provides a durable chemical hook from the nylon to the THA that increases the number of available ionic bond locations by a factor of 3.
For the purpose of this disclosure, a durable chemical bond or binding site is one which will not be broken by skin conditions such as skin pH (about 5.5), skin moisture or skin heat due to friction or body heat. The durable bond also will not be broken due to ordinary washing.
The ionic or semi-durable bond requires a low PH (less than 5 pH). The THA may be complexed with a compound known as SILANTRIOL, which is known to improve the passage of chemicals through human skin.
The ionic bond is here referred to as a semi-durable which is broken by one or more skin conditions selected from skin pH, skin moisture, and/or skin heat (due to friction or body heat). The semi-durable bond is not broken, however, by washing the garment in a usual way (i.e. with detergent, warm water and agitation). Stated otherwise, xe2x80x9csemi-durable bondsxe2x80x9d means the ionic bonds of the PEI with the active ingredients of this invention, while xe2x80x9cdurable bondsxe2x80x9d means the concurrent covalent bonds of the PEI to the fiber matrix of the garments.
When the pantyhose are worn, the THA is gradually released to the wearer""s skin from the ionic bond, and the pantyhose, due to a combination of three factors: pH increased above 5 by contact with wearer""s skin (skin pH is about 5.5); moisture from wearer""s skin; and body and friction heat (collectively skin heat). Over time, the THA has the effect of reducing cellulite. The pantyhose may be xe2x80x9crechargedxe2x80x9d by soaking it in a solution of THA.
The pantyhose are chemically treated in a multistep process to bond the PEI and THA to the pantyhose. First, the pantyhose are washed twice in distilled water and damp dried. Then, the pantyhose are immersed in a solution of PEI for 30 minutes with constant agitation. Following immersion, the pantyhose are washed twice in deionized water and damp dried. The PEI is now permanently bonded with the nylon of the pantyhose, creating the chemical hook to ionically bond THA or other substances.
Meanwhile, the THA-SILANTRIOL complex is prepared by incrementally adding SILANTRIOL to a solution of THA at a pH of 5.5. The pH of the THA-SILANTRIOL complex is then reduced below 5 prior to the next step.
To ionically bond the THA-SILANTRIOL complex to the PEI, the pantyhose with the PEI chemical hook are immersed in a solution of the THA-SILANTRIOL complex for 3 hours with constant agitation. The pantyhose are then washed twice in deionized water and dried.
The resulting chemically treated pantyhose may be stored in the dry state indefinitely without decomposition of any of the compounds or chemical bonds.
In an alternative embodiment of the present invention, the nylon pantyhose, or stocking, still preferentially employs polyethylenimine (PEI) as the agent for permanently chemical bonding to the nylon fabric, and also employ one of ascorbic acid, lipoic acid, or an isoflavone, like genistein, being bonded by a semi-durable chemical bonds to the PEI, with those serving as the active ingredients. As with the theophylline compound being the first disclosed active ingredient, the herein disclosed active ingredients may be complex with silanols, like silantriol, which agents are known to aid absorption of the selected active ingredients through human skin.
Accordingly an object of the present invention is to provide a garment for treating the skin of a wearer with an active ingredient, comprising a garment material having a multiplicity of durable chemical binding sites, a binding agent molecule chemically bound to each of the durable binding sites, each binding agent molecule having at least one semi-durable chemical binding site which can be broken by at least one of skin pH, skin moisture and skin heat, and an active ingredient molecule bound to each semi-durable chemical binding site so that the active ingredient is chemically bound to the garment when the garment is not worn and so that the active ingredient is released to the skin when the garment is worn and the semi-durable binding sites are exposed to at least one of skin pH, skin moisture and skin heat to break bonds between the active ingredient molecules and the binding agent molecules.
Another object of the present invention is to provide a method of making such a garment and a method of treating the skin with such a garment.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which the preferred embodiments of the invention are illustrated.